Arrhythmia in ChildrenNCT04768634
Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
A study testing Provocative electrophysiology study in people with Arrhythmia in Children and Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
Trial summary
In this research study we want to learn more about abnormal heart rhythm after cardiac surgery in children. These abnormal heart rhythms, also called arrhythmias, may occur due to several reasons after cardiac surgery. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Arrhythmia in Children, Congenital Heart Disease
- What is being tested?
- Provocative electrophysiology study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2021to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged < 18 years of age on admission to the cardiac intensive care unit following cardiac surgery with a predicted probability of supraventricular tachycardia >10%
Who cannot join
- Patients following orthotopic heart transplant, ventricular assist device implantation, primary extracorporeal membrane oxygenation cannulation, pacemaker or implantable cardioverter-defibrillator implantation or sympathectomy
- Patients on antiarrhythmic medication at the time of surgery
- Patients with atrioventricular conduction disease (1st degree atrioventricular block with PR interval greater than 200 ms, 2nd degree atrioventricular block or complete heart block)
- Patients with severe ventricular dysfunction in whom therapy with beta-blocker or sotalol is deemed contra-indicated by the primary team
- Patients with absent or non-functioning atrial pacing wires
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
In this research study we want to learn more about abnormal heart rhythm after cardiac surgery in children. These abnormal heart rhythms, also called arrhythmias, may occur due to several reasons after cardiac surgery. They can be due to abnormal electrical pathway or an irritable area of the heart that stimulates abnormal impulses. Regardless of the cause, arrhythmias after cardiac surgery can be a problem, extending the hospital stay, requiring additional medications and even leading to cardiac arrest.
Current practice is to monitor for arrhythmias after cardiac surgery, and to treat them if they occur. With this research, we want to investigate whether we can identify patients who will develop arrhythmia, and treat them before they occur.
Read the detailed description
This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management
- Conditions
- Arrhythmia in Children, Congenital Heart Disease
- Being tested
- Provocative electrophysiology study
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provocative electrophysiology studyDiagnostic test
Provocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Patients will be observed for arrhythmias and treated if they occur. |
| Testing | Experimental | Patients will undergo provocative electrophysiology testing, and antiarrhythmic medication considered if arrhythmias can be induced. Receives: Diagnostic Test: Provocative electrophysiology study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with supraventricular tachycardia
Number of days post-operatively at time of supraventricular tachycardia
Measured: Through hospital discharge after cardiac surgery, or up to 90 days
Secondary outcomes (9)
Number of patients with adverse events related to provocative electrophysiology testing
Measured: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with sustained supraventricular tachycardia
Number of days post-operatively at time of sustained supraventricular tachycardia
Measured: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with other tachyarrhythmias
Measured: Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively at time of extubation
Measured: Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively in the intensive care unit
Measured: Though hospital discharge
Number of days in the hospital
Measured: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with adverse events related to antiarrhythmic treatment
Measured: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with major adverse cardiac events (including need for CPR, ECMO or death)
Measured: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with supraventricular tachycardia after hospital discharge
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start23 Mar 2021
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Why it stopped: limited enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmia in ChildrenStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, The Children's Heart Foundation
- Responsible party
- Principal investigator, Audrey Dionne, Boston Children's Hospital
- Investigators
- Audrey Dionne, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768634
- Sponsor's protocol ID
- IRB-P00037574
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
- ClinicalTrials.gov ID
- NCT04768634
- Acronym / sponsor ID
- IRB-P00037574
- Conditions
- Arrhythmia in Children, Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: limited enrollment
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- American Heart Association, The Children's Heart Foundation
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study we want to learn more about abnormal heart rhythm after cardiac surgery in children. These abnormal heart rhythms, also called arrhythmias, may occur due to several reasons after cardiac surgery. They can be due to abnormal electrical pathway or an irritable area of the heart that stimulates abnormal impulses. Regardless of the cause, arrhythmias after cardiac surgery can be a problem, extending the hospital stay, requiring additional medications and even leading to cardiac arrest.
Current practice is to monitor for arrhythmias after cardiac surgery, and to treat them if they occur. With this research, we want to investigate whether we can identify patients who will develop arrhythmia, and treat them before they occur.
Detailed description
This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –Patients will be observed for arrhythmias and treated if they occur. |
| Testing | Experimental | Diagnostic Test: Provocative electrophysiology studyPatients will undergo provocative electrophysiology testing, and antiarrhythmic medication considered if arrhythmias can be induced. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients aged < 18 years of age on admission to the cardiac intensive care unit following cardiac surgery with a predicted probability of supraventricular tachycardia >10%
Key exclusion criteria (5 listed)
- Patients following orthotopic heart transplant, ventricular assist device implantation, primary extracorporeal membrane oxygenation cannulation, pacemaker or implantable cardioverter-defibrillator implantation or sympathectomy
- Patients on antiarrhythmic medication at the time of surgery
- Patients with atrioventricular conduction disease (1st degree atrioventricular block with PR interval greater than 200 ms, 2nd degree atrioventricular block or complete heart block)
- Patients with severe ventricular dysfunction in whom therapy with beta-blocker or sotalol is deemed contra-indicated by the primary team
- Patients with absent or non-functioning atrial pacing wires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provocative electrophysiology studyProvocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery. | Diagnostic test | Testing |
Primary outcome
Number of patients with supraventricular tachycardia
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively at time of supraventricular tachycardia
9 secondary outcomes
Number of patients with adverse events related to provocative electrophysiology testing
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with sustained supraventricular tachycardia
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with other tachyarrhythmias
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively at time of extubation
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively in the intensive care unit
Time frame: Though hospital discharge
Number of days in the hospital
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with adverse events related to antiarrhythmic treatment
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with major adverse cardiac events (including need for CPR, ECMO or death)
Time frame: Through hospital discharge after cardiac surgery, or up to 90 days
Number of patients with supraventricular tachycardia after hospital discharge
Time frame: 12 months
Results and safety
The study was stopped early (reason given: limited enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Dionne, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provocative electrophysiology study in people with Arrhythmia in Children and Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: limited enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with supraventricular tachycardia (time frame: Through hospital discharge after cardiac surgery, or up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.